Effect of excipients on the stability of levothyroxine sodium tablets.
Levothyroxine sodium tablets from two different manufacturers were analysed using the USP-NF method of analysis, a stability-indicating high pressure liquid chromatographic (HPLC) procedure. The results indicate that one particular manufacturer's 0.2-mg pink tablets contain some excipient(s) which act as a catalyst to hasten decomposition after extraction of levothyroxine for analysis. The same tablets from a different batch showed an additional long peak in the chromatogram, which indicated that the excipient(s) may have been changed. The same manufacturer has also used three different types of bottles/lids for the same product during the last year. Good manufacturing practice requires that new compatibilities/stability studies be conducted to assure the quality of the product. Ongoing stability studies are required by the Food and Drugs Administration (FDA). The use-life of 0.2-mg pink tablets of this manufacturer may be short.
Das Gupta
V
V
University of Houston, TX 77030.
Odom
C
C
Bethea
C
C
Plattenburg
J
J
D000077713:17 alpha-Hydroxyprogesterone Caproate; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005079:Excipients; D006908:Hydroxyprogesterones; D008027:Light; D012015:Reference Standards; D012972:Sodium Hydroxide; D013607:Tablets; D013974:Thyroxine / Q000737:chemistry* / Q000528:radiation effects
D005079:Excipients; D006908:Hydroxyprogesterones; D013607:Tablets; D000077713:17 alpha-Hydroxyprogesterone Caproate; D012972:Sodium Hydroxide; D013974:Thyroxine